DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Active, not recruiting

Conditions: Participation Rate, Patient; Patient Participation

Treatments: Other: participation rate

Study type: Observational

Funder types: Other

Identifiers

NCT06486402

W23_111 # 23.136

Details and patient eligibility

About

The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.

To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
• adult patients undergoing various types of medical surgeries.

Exclusion criteria

. studies which excluded or did not equally approach women beforehand